MD300C5 FDA Operator`s Manual
Contents
1. MD300C5 is intended only as an adjunct in patient assessment It must be used in conjunction with other methods of assessing clinical signs and symptoms l Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the patient l Do not stretch the adhesive tape while applying the pulse oximeter sensor This may cause inaccurate readings or skin blisters I Before use carefully read the manual l The MD300C5 has no SpO2 alarms it is not for continuous monitoring as indicated by the symbol l Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours l Do not sterilize the device using autoclaving ethylene oxide sterilizing or immersing the sensors in liquid which may cause inaccurate readings The device is not intended for sterilization l Significant levels of dysfunctional hemoglobins such as carbonxy hemoglobin or methemoglobin I Intravascular dyes such as indocyanine green or methylene blue l SpO2 measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel or direct sunlight for example if necessary Excessive patient movement High frequency electrosurgical interference and defibrillators Venous pulsations Placement of a sensor on an extremity with a b2. electromagnetic immunity For all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and Manufacture s declaration electromagnetic immunity Guidance and Manufacture s declaration electromagnetic environment specified below The customer of the user of the Pulse Oximeter MD300C5 should assure that it is used in such an environment Immunity IEC 60601 test Compliance Electromagnetic Environment guidance test level Level Radiated 3 V m 3 V m Portable and mobile RF communications equipment RF 80 MHz to 2 5 should be used no closer to any part of the Pulse Oximeter IEC GHz MD300C5 including cables than the recommended 61000 4 3 separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance afi r Lh 80 MHz to 800 MHz je nb 3 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by abso
3. s declaration electromagnetic immunity For all EQUIPMENT and SYSTEMS Guidance and Manufacture s declaration _ electromagnetic immunity Guidance and Manufacture s declaration electromagnetic environment specified below The customer of the user of the Pulse Oximeter MD300C5 should assure that it is used in such an environment Immunity test IEC 60601 test Compliance Electromagnetic Environment guidance level Level Electrostatic kV contact H kV Floors should be wood concrete or ceramic Discharge ESD 8KV air contact tile If floor are covered with synthetic IEC 61000 4 2 8kV air material the relative humidity should be at least 30 PDF SCeEERA pdfFactory Pro iA A AMA GIE www fineprint cn Refer to user manual before application EN No for continuous monitoring z PDF X4HEH pdfFactory Pro WHIRI www fineprint cn
4. Information Manual Version FDA 1 0C5 MD300C5 0123 Fingertip Pulse Oximeter The oximeter is calibrated to display functional oxygen saturation Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin R Hb and Oxyhemoglobin O2 Hb in glow and near infrared zones Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology so that two beams of different wavelength of lights 660nm glow and 940nm near infrared light can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on two groups of LEDs through process in electronic circuits and microprocessor 2 Precautions for use l Operation of MD300C5 may be affected by the use of an electrosurgical unit ESU l The MD300C5 must be able to measure the pulse properly to obtain an accurate SpO2 measurement Verify that nothing is hindering the pulse measurement before replying on the SpO2 measurement Do not use the MD300C5 in an MRI or CT environment Do not use the MD300C5 in situations where alarms are required The device has no alarms Explosion hazard Do not use the MD300C5 in an explosive atmosphere The
5. according to frequency of transmitter m power of transmitter 80 MHz to 800 MHz 800 MHz to 2 5 GHz w 0 01 0 1167 0 2334 0 1 0 3689 0 7378 1 1 1667 2 3334 10 3 6893 7 3786 100 11 6667 23 3334 Emission test Compliance Electromagnetic Environment guidance RF emissions CISPR 11 Group 1 The pulse Oximeter MD300C5 uses RF energy only for very low and are not likely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class B The pulse Oximeter IMD300C5 is suitable for Harmonic emissions Not Applicable use in all establishment including domestic IEC 61000 3 2 establishments and those directly connected Voltage fluctuations flicker Not Applicable to the public low voltage power supply emissions network that supplies buildings used for IEC 61000 3 2 domestic purposes For transmitters rated at a maximum output power not listed above the recommended sepratation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and Manufacture
6. d to enter any openings in the device Allow the oximeter to dry thoroughly before reusing l The functional tester cannot be used to assess the accuracy of the oximeter I Index 2 that made by Bioteck company is a function tester Set Tech to 1 R curve to 2 then user can use this particular calibration curve to measure the oximeter l The test methods used to establish the SpO2 accuracy is clinical testing The oximeter used to measure the arterial haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO oximeter 14 Possible Problems and res Solution 1 Retry by plugging the finger 2 There is excessive illumination 3 Measure more times If you can make sure about no problem existing in the product Please go to a hospital timely for exact diagnosis Problems Possible reason SpO2 or pulse rate can not be shown normally 1 Finger is not plugged correctly 2 Patient s SpO2value is too low to be measured SpO2 or pulse rate is shown unstably 1 Finger might not be plugged deep enough 2 Excessive patient movement 1 Retry by plugging the finger 2 Be calmness Power frequency 50 60 3A m 3A m Power frequency magnetic fields should be Hz magnetic field at levels characteristics of a typical location IEC 61000 4 8 in a typica commercial or hospital environment Guidance and Manufacture s declaration
7. es 5 1 Operation of the product is simple and convenient 5 2 The product is small in volume light in weight total weight is about 50g including batteries and convenient in carrying 5 3 Power consumption of the product is low and the two originally equipped two AAA batteries can be operated continuously for 30 hours 5 4 Low voltage warning will be indicated in visual window when battery voltage is so low that normal operation PDF SceEERA pdfFactory Pro iAH ARABI www fineprint cn of the Oximeter might be influenced 5 5 The product will automatically be powered off when no signal is in the product for longer than 8 seconds 5 6 PR tone modulation 5 7 Brightness adjustment 6 Product Intended Use Intended Use Fingertip Pulse Oximeter MD300C5 is a portable non invasive spot check oxygen saturation of arterial hemoglobin SpO2 and pulse rate of adult and pediatric patient at home and hospital including clinical use in internist surgery Anesthesia intensive care and etc Not for continuously monitoring The MD300C5 requires no routine calibration or maintenance other than replacement of batteries 7 Operation Instructions 7 1 Installing two AAA batteries into battery cassette before covering its cover 7 2 Open the clamp as illustrated in the picture below 7 3 Plug one of fingers into rubber hole of the Oximeter it is best to plug the finger thoroughly before releasing the clamp 7 4 Press the switch button once on fr
8. lood pressure cuff arterial catheter or intravascular line The patient has hypotension severe vasoconstriction severe anemia or hypothermia The patient is in cardiac arrest or is in shock Fingernail polish or false fingernails may cause inaccurate SpO2 readings Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries aTechnical Specifications 4 1 Display type LCD display SPO2 display range 0 100 PR display range 30 235 BPM PR display mode bargraph Data update time lt 15s 4 2 LED Wavelengths Red 660nm Infrared 940nm 4 3 Battery life Two AAA 1 5V alkaline batteries could be continuously operated as long as 30 hours 4 4 Resolution 1 for SPO2 and 1BPM for Pulse rate 4 5 Measurement Accuracy SPO2 70 100 3 lt 70 no definition PR 30 235 BPM 2 bpm during the pulse rate range of 30 99 bpm and 2 during the pulse rate range of 100 235 bpm 4 6 It is equipped with a function switch through which the Oximeter can be powered off in case no finger is the Oximeter longer than 8 seconds 4 7 Outline dimension Length 50mm Width 28mm Height 28mm Weight 25g without two AAA batteries 4 8 Environment requirements Operation Temperature 5 40 C Storage Temperature 20 70 C Humidity 15 80 in operation lt 93 in storage Declaration EMC of this product comply with IEC60601 1 2 standard 5 Product Properti
9. obile RF communications equipment transmitters and the Pulse Oximeter MD300C5 as recommended below according to the maximum output power of the communications equipment not be powered 2 Battery might be installed 2 Please reinstall the battery incorrectly 3 Please contact with local customer on 3 The Monitor might be damaged service centre 1 The oximeter is automatically Indication is powered off when no signal is 1 Normal suddenly off detected longer than 8 seconds 2 The batteries power is too low to 2 Replace the battery work Error3 or 1 Err 3 means the red emission 1 Check the red emission LED Error4 Displayed LED is damaged 2 Check the infra red emission LED onscreen 2 Err 4 means the infra red emission LED is damaged Error 6 Err 6 means the crystal is failure Change the crystal Error7 displayed Err 7 means all the emission LED or Check the emission LED and reception onscreen reception dioxide is damaged dioxide Declaration Guidance and Manufacture s declaration electromagnetic emissions For all EQUIPMENT and SYSTEMS Guidance and Manufacture s declaration _ electromagnetic emission Guidance and Manufacture s declaration electromagnetic environment specified below The customer of the user of the Pulse Oximeter MD300C5 should assure that it is used in such and environment Rated maximum output Separation distance
10. ont panel 7 5 Your finger do not tremble during the Oximeter is working Your body is not recommended in moving status 7 6 Read correspondent datum from display screen 7 7 Six display modes After turn on the oximeter each time you press the power switch the oximeter will switch to another display mode there are 6 display modes shown as follows Display Mode Description Display mode when opening horizontal and normal facing the device PEZ 19 Titep 75 After 1 click the display is horizontal but handstand facing After 1 click again the display is vertical and handstand facing After another click the display is vertical and normal facing After another click again the display is horizontal and normal facing with wave shape filled form display After 1 click once more the display is horizontal and normal facing with wave shape wire form display When you press the power switch for a long time more than one second the brightness of the oximeter will be changed by degrees there are 10 levels on hriahtness the default level is level four pE Tite When your finger is plug 9 8 75 our nail surface must be upward 8 Brief Description of Front Low ME eo Lnn I Ht ea lee an 4 95 34 Power switch PR Bargraph_ y 9 8 77 y a SPO2 waveform Miate ss g a ales aad Sp02 Pulse Rate 9 Product Acceg 9 1 One hang lace 9 2 Two batteries 9 3 One instruc
11. rption and reflection structures objects and people A Field strengths from fixed transmitters such as base station for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Pulse Oximeter MD300C5 should be observed to verify normal operation If abnormal performance is observed additional measurements may be necessary such as reorienting of the relocating the Pulse Oximeter MD300C5 B_ Over the frequency range 150 kHz to 80 MHz fields strengths should be less than 3 V m 1 No battery or low power of battery 1 Please replace battery The Monitor can Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS For all EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and Pulse Oximeter MD300C5 The Pulse Oximeter MD300C5 is intended for use in electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Pulse Oximeter MD300C5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and m
12. tion manual 10 Battery Installq 10 1 Put the two AAA be 10 2 Push the battery cc Notes Battery polarities must be correctly installed Otherwise damage might be caused to device Please put or remove batteries in right order or is likely to damage the device bracket Please remove the battery if the Oximeter will not be used for long time 11 Hang Lace Installations 11 1 Thread thinner end of the hang lace through the hanging hole 11 2 thread thicker and of the lace through the threaded end before pulling it tightly 12 1 Replace the batteries timely when low voltage lamp is lighted 12 2 Clean surface of the fingertip Oximeter before it is used in diagnosis for patients 12 3 Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time 12 4 It is best to preserve the product in a place where ambient temperatures 10 40 C 14 104 F and humidity is 10 80 It is recommended that the product should be kept in a dry environment anytime A wet ambient might affect its lifetime and even might damage the product Please follow the law of the local government to deal with used battery Cleaning the MD300C5 Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter with a soft cloth dampened with 70 isopropyl alcohol and clean the test finger using alcohol before and after each test Do not pour or spray and liquids onto the oximeter and do not allow any liqui
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